Rize 2 The Occasion, Rose 4 Her Capsules Recalled for Potentially Harmful, Undeclared IngredientsJul 3, 2008 | Parker Waichman LLP
In what seems to be a rash of such recalls, Jack Distribution, LLC of Pompano Beach, Florida—and its wholesale distributors G & N Works, Inc, and Devine Distribution Inc.—issued a voluntary nationwide recall of selected lots of Rize 2 The Occasion and Rose 4 Her capsules. The products were marketed as dietary supplements but some lots contain thiomethisosildenafil, an undeclared ingredient similar in chemical structure to sildenafil, an FDA-approved erectile dysfunction (ED) medication.
The Food and Drug Administration (FDA) advised Jack Distribution that its lab analysis of Rize 2 and Rose 4 Her samples from lots manufactured and packaged in 2007 found the products contain thiomethisosildenafil, a potentially harmful, undeclared ingredient. Thiomethisosildenafil is expected to possess a similar pharmacological and adverse event profile as sildenafil and poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs, such as nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and these types of products may be used to enhance sexual performance.
The recall involves Rize 2 The Occasion capsules with the following lot numbers and expiration dates: CG-84 and 11/10, GD-98 and 08/10, CC-06 and 06/10, 709 and 09/10, and CG-79 and 11/10. Rose 4 Her capsules with the lot and expiration number CG-78 and 11/10 are also recalled. Rize 2 and Rose 4 Her are sold in adult stores, vitamin and nutrition shops, convenience stores, and via the Internet nationwide. The Rize 2 product is sold as a single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.
Jack Distribution confirmed that unused portions from these lot numbers returned to the place of purchase will receive a full refund of the purchase price. G & N Works and Devine Distribution are not shipping any Rize 2 or Rose 4 Her in stock while additional samples are being tested but expect to begin shipping again in two-to-four weeks.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking these products. Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
In May, International Pharmaceuticals, Ltd. of Bradford, Massachusetts recalled lots of its supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs and SEI Pharmaceuticals of Miami, Florida recalled lots of Xiadafil VIP Tabs. Both recalls were implemented after samples were found to contain a potentially harmful undeclared ingredient—an analog of sildenafil, an FDA-approved erectile dysfunction (ED) medication.